Abstract: A system includes an outer catheter and an inner catheter. The outer catheter has a proximal end and a distal end. The distal end has a discharge nozzle, a tapered interior wall, and an end orifice. The proximal end is configured to receive a fluid. The discharge nozzle is coupled to the proximal end by a first lumen. The discharge nozzle is configured to direct the fluid in a plurality of discrete streams aligned in a radial fashion about an axis of the first lumen. The interior catheter is configured for placement within the first lumen. A first end of the interior catheter includes an occluder and includes a first temperature sensor. The first temperature sensor is configured to pass through the end orifice. The occluder is configured to engage with the tapered interior wall in a fluid-tight seal. The first temperature sensor includes a sense surface and includes a signal node. The signal node is configured to provide a first signal corresponding to a timewise change in temperature at the sense surface.

Abstract: A medical device system is provided herein which has an elongated, flexible hollow member with an expandable infusion segment attached at the most distal end of the device. The device has a plurality of fluid infusion ports on the expandable infusion segment for delivering an intended fluid to a target site in a body lumen. Additionally, a method is provided herein for infusing an intended fluid to a target site within a body lumen.

Abstract: A medical device and medical method. The medical device includes a flexible elongate body defining a proximal end and a distal end. The elongate body defines a first lumen spanning from the proximal end to a location proximal to the distal end. A shaping member insertable within the first lumen is included, the shaping member is configured to retain a manipulated shape when the flexible elongate body is manipulated from a first configuration to a second configuration. A tip is coupled to the distal end.

Abstract: A catheter securement bandage may include a base layer formed with a multi-ply laminate comprising adhesive, gauze, and plastic layers. A top layer may similarly be formed with a multi-ply laminate comprising a layer adhesive, plastic, gauze, and an added layer of adhesive. By securing a hub portion and lure connector of a catheter, the catheter securement bandage maintains an optimal catheter insertion angle of the catheter into a patent this preventing kinking and obstruction of flow through the catheter.

Abstract: Intravascular devices, systems, and methods are disclosed. In some instances, the intravascular device is a guide wire with distal tip element having a radiopaque marker pattern. For example, in some implementations a sensing guide wire includes a flexible elongate member; a sensing element coupled to the flexible elongate member; a flexible tip element coupled to and extending distally from the sensing element, the flexible tip element having a first radiopaque section, a second radiopaque section, and a non-radiopaque section positioned between the first and second radiopaque sections. Methods of making, manufacturing, and/or assembling such intravascular devices and associated systems are also provided.

Abstract: A system for conducting denervation of the neural plexus adjacent the renal artery, comprises a pre-shaped ablative element operatively coupled to an elongate deployment member configured to be navigated into the renal artery, the pre-shaped ablative element comprising one or more RF electrodes disposed in an arcuate pattern; and an energy source operatively coupled to the one or more RF electrodes and being configured to cause current to flow from the pre-shaped ablative element and cause localized heating sufficient to denervate nearby neural tissue.

Abstract: Provided is a coated implantable medical device, comprising: a substrate; and a coating disposed on the substrate, wherein the coating comprises at least one polymer and at least one pharmaceutical agent in a therapeutically desirable morphology and/or at least one active biological agent and optionally, one or more pharmaceutical carrying agents; wherein substantially all of pharmaceutical agent and/or active biological agent remains within the coating and on the substrate until the implantable device is deployed at an intervention site inside the body of a subject and wherein upon deployment of the medical device in the body of the subject a portion of the pharmaceutical agent and/or active biological agent is delivered at the intervention site along with at least a portion of the polymer and/or a at least a portion of the pharmaceutical carrying agents.

Abstract: An intravascular catheter for peri-vascular or peri-urethral tissue ablation includes multiple needles advanced through supported guide tubes which expand around a central axis to engage the interior surface of the wall of the renal artery or other vessel of a human body allowing the injection an ablative fluid for ablating tissue, such as nerve fibers in the outer layer or deep to the outer layer of the vessel, or in prostatic tissue. The system may also control the depth of penetration of the ablative fluid into and beyond the tissue of the vessel wall. The catheter may also include structures which provide radial or lateral support to the guide tubes so that the guide tubes expand uniformly and maintain their position against the interior surface of the vessel wall as the sharpened injection needles are advanced to penetrate into the vessel wall.

Abstract: A device for winding a filament around a structure disposed concentrically around a distal end of a balloon catheter includes a rotatable holder for retaining a distal end of the balloon catheter, a translatable winding carriage for helically winding the tensioned filament around the balloon catheter distal end, a heater for applying a predetermined amount of heat to a section of the balloon catheter having the filament wound therearound, and a controller for controlling at least the rate of rotation of the holder, the tensioning force applied to the filament, the amount of heat applied by the heater, and the rate of travel of the translatable winding carriage along the longitudinal dimension of the balloon catheter. By use of the device, the balloon is heat set and a predetermined checkering pattern of surface indentations are provided in the structure exterior surface in a single pass.

Abstract: A balloon coating method for forming a coating layer containing a water-insoluble drug on the outer surface of a balloon of a balloon catheter. The method includes applying a first rotation force to the balloon catheter proximal to the balloon of the balloon catheter and applying a second rotation force to the balloon catheter distal to the balloon of the balloon catheter. The first rotation speed is the same as the second rotation speed. The method includes applying a coating solution containing the drug to the outer surface of the balloon from a dispensing tube while gradually moving the dispensing tube in the axial direction and simultaneously applying the first and second rotation forces to rotate the balloon catheter around the longitudinal axis of the balloon catheter.

Abstract: A system for supporting or dilating a body vessel includes a balloon catheter with a shaft having a delivery lumen in communication with an interior of the balloon. The balloon includes holes formed in the outer wall of the balloon. Additional or daughter balloons are delivered through the delivery lumen into the cavity of the balloon and through the holes into engagement with the holes. The daughter balloons are inflatable to seal against the holes, and the main balloon is subsequently inflatable when sealed by the daughter balloons. The daughter balloons may be delivered to branch vessels to provide support in addition to the inflation of the main balloon. The system may include preloaded wires extending through the delivery lumen and through the holes, and the daughter balloons can be delivered over the wires to the desired location.

Abstract: A device and method for dilating a Eustachian tube of a patient is disclosed. The device includes a guide catheter and a balloon dilation catheter. The balloon dilation catheter has an actuator that prevents injury to the middle ear. The balloon dilation catheter is slidably coupled with the guide catheter through the guide catheter lumen and is fully inserted into the guide catheter lumen when the distal side of the actuator is adjacent to the proximal end of the guide catheter. The method involves advancing the guide catheter and balloon dilation catheter through a nasal passage of the patient to dilate a portion of the Eustachian tube.

Abstract: A device for reducing pressure within a lumen includes a reservoir structured for holding a fluid therein, an injection port in fluid communication with the reservoir, a compliant body structured to expand and contract upon changes in pressure, and a conduit extending between and fluidly coupling the reservoir and the compliant body. The fluid may be a compressible or a noncompressible fluid.

Abstract: The present invention provides an apparatus for producing medical foam for wound care or hair stimulation. The apparatus includes a foam generation unit having a fluid reservoir, a fluid delivery line and a foam generation tip. The apparatus also includes a compressed gas unit having at least one container of compressed gas, a source of electric power, and a gas regulator valve. A supply of wound care or hair stimulating solution is communicably connected to the foam generation tip such that when the apparatus is operated medical foam is produced by the foam generator tip.

Abstract: A medical fluid suspension generating apparatus for performing medical procedures includes a Venturi-agitating tip assembly composed of a multi-channel arrangement at a proximal first end thereof and a tip at a distal second end thereof. The apparatus also includes a compressed medical fluid unit fluidly connected to the multi-channel arrangement at a proximal first end of the Venturi-agitating tip assembly and a medical solution fluidly connected to the multi-channel arrangement at a proximal first end of the Venturi-agitating tip assembly. Pressurized gas, from the compressed medical fluid unit, and the medical solution are combined within the Venturi-agitating tip assembly in a manner generating an enriched medical suspension that is ultimately dispensed from the suspension delivery apparatus.

Abstract: The present invention provides apparatus and methods for making multiple aseptic fluid interconnections in parallel with an integral clamping mechanism and elastomeric fluid sealing gasket to provide an initial fluid tight seal while removing sealing tape tabs and a final fluid tight seal after sealing tape tabs are removed. The clamping mechanism comprises a hinge coupling and a first set of snap-fit locks to maintain the initial fluid tight seal and a second set of snap-fit locks to maintain the final fluid tight seal.

Abstract: Disclosed herein are embodiments of a connector system for releasably connecting together tubes, for example medical tubing, and methods of making and using such a connector system, whereby the connector system includes a female coupler having a first passageway; a male coupler having a second passageway; and a catch assembly comprising a catch movably coupled to the female coupler, a catch-biasing member which biases the catch, and a follower responsive to a cam, whereby the catch is responsive to the follower and correspondingly, the cam.

Abstract: A pumping system comprising a pump comprising a door for access within a housing of the pump, a pump segment configured for conveying a fluid based on compression of the pump segment, a pump segment frame for preventing said pump segment from stretching, a visual placement indicator configured for facilitating in a proper placement of the pump segment frame in the housing, and a non-pinching valve configured to be disposed in the housing and to control a flow of the fluid without requiring pinching of a tube.

Abstract: A needleless valve system includes a cannula comprising a cannula tip; a valve comprising a valve tip, wherein the valve is disposed around the cannula; and a housing comprising a housing tip, wherein the cannula tip, the valve tip, and the housing tip comprise a flat surface when the needleless valve system is in a sealed position.

Abstract: Method and systems for determining a set of stimulation parameters for an implantable stimulation device include receiving a set of stimulation parameters including at least one electrode for delivery of stimulation and a stimulation amplitude for each electrode; determining, using the set of stimulation parameters, an axial stimulation field for neural elements oriented axially with respect to a longitudinal axis of the lead; and outputting the first axial stimulation field for viewing by a user; receiving, by the computer processor. The methods and systems can be used to model other neural elements oriented non-orthogonally with respect to the longitudinal axis of the lead and determine a non-orthogonal stimulation field.

Abstract: System, method, and tool for implanting an electrode cuff. The system can include a cuff and a slider implement, where the cuff is temporarily retained within and/or onto the slider implement by a retainer mechanism during implantation. The cuff can be structured to exhibit a natural rolled shape, but can be resiliently bendable so as to flex from the rolled shape while having a tendency to move back to the rolled shape. The cuff can be releasably secured to a portion of the slider implement, which may include holding the cuff in an unrolled shape. The cuff can then be positioned adjacent the nerve. The retainer mechanism can then be actuated to allow the cuff to advance towards its naturally rolled shape, thereby wrapping around the nerve.

Abstract: Devices and methods of use for introduction and implantation of an electrode as part of a minimally invasive technique. An implantable baroreflex activation system includes a control system having an implantable housing, an electrical lead, attachable to the control system, and an electrode structure. The electrode structure is near one end of the electrical lead, and includes a monopolar electrode, a backing material having an effective surface area larger than the electrode, and a releasable pivotable interface to mate with an implant tool. The electrode is configured for implantation on an outer surface of a blood vessel and the control system is programmed to deliver a baroreflex therapy via the monopolar electrode to a baroreceptor within a wall of the blood vessel.

Abstract: An electrode head of an implantable electrode line, the electrode head including an elongate housing which has a longitudinal axis. The elongate housing includes at least two housing parts, which are cylinder-segment-shaped at least in portions and are fixedly joined together to form the electrode head along the longitudinal axis.

Abstract: A catheter inner assembly includes a receptacle with an interior contour configured to mate with a head and neck contour of a holding member of an implantable medical device; and a laterally facing opening of the receptacle has a profile matching a longitudinal profile of the head and neck. Thus, the opening allows only a properly oriented passage of the holding member therethrough, the passage being without deformation of holding member or opening. The inner assembly further includes a lock and release member useful for securing the device to the catheter, when the holding member has been passed through the receptacle's opening to mate with the receptacle's interior contour. The lock and release member may include an arcuate sidewall moveable between a first location, at which the sidewall overlays the laterally facing opening, and a second location, at which the sidewall is located proximal to the opening.

Abstract: A method and instrument for treating the toxic effect a patient experiences as a result of insect bites and snakebites comprises applying multiple instantaneous 20,000 to 30,000 volt electric discharges from a hand-operated piezoelectric device to a site of the bite.

Abstract: A device is provided for stimulating neurons that includes a non-invasive stimulation unit that generates stimuli in multiple stimulation channels. The stimulation unit generates the stimuli to stimulate a neuron population in the brain and/or spinal cord of a patient using the stimulation channels in different locations. Moreover, the device includes a control unit that controls the stimulation unit to repeatedly generates sequences of the stimuli with the order of the stimulation channels in which stimuli are generated within a sequence being constant for 20 or more successively generated sequences before it is varied.

Abstract: Devices, systems and methods for treating medical disorders, such as migraine or other primary headaches, or fibromyalgia, by noninvasive electrical stimulation of a vagus nerve, used in conjunction with the measurement of evoked potentials (EPs). The system comprises a stimulator that is applied to the surface of the patient's neck to apply electrical impulses sufficient to stimulate a cervical vagus nerve, scalp electrodes that are used to measure EPs that are evoked by that stimulation, feedback or biofeedback circuits to vary the stimulation based upon EP characteristics, and other sensory stimulation modalities that produce EPs. The system is preferably used to optimize the placement of the stimulator, to test whether a patient is a suitable candidate for treatment using vagus nerve stimulation, and to select the stimulation parameters that optimized acute or chronic treatment, e.g., by correcting an EP habituation deficit.

Abstract: A nerve stimulation system including one or more of an annular frame, an electrically conductive element disposed in the annular frame, and a controller electrically coupled to the electrically conductive element and a power source.

Abstract: A computer implemented system and method generates a patient-specific model of patient response to stimulation on a neural element basis, receives user-input of target neuromodulation sites, and, based on the patient-specific model, determines which stimulation paradigm and settings, including stimulation sites, would result in the target neuromodulation, where the stimulation sites are not necessarily the same as the resulting neuromodulation sites. The system outputs a visual representation of the stimulation sites that would result in the target neuromodulation. The system monitors a system state and/or patient state and dynamically changes which stimulation program to implement based on the state.

Abstract: A stimulator and a method for the treatment of intractable pain syndromes by electrical stimulation of the spinal cord is disclosed. An example method includes positioning a first pair of implantable electrodes to a dura matter in an epidural space proximate to a subject's spinal cord at predetermined locations, positioning a second pair of implantable electrodes to the dura matter in the epidural space proximate to the subject's spinal cord at predetermined locations, and transmitting signals of first and second frequencies through the first and second pairs of implantable electrodes respectively, so that the signals of the first and second frequencies interfere with each other to produce at least one beat signal proximate to the subject's spinal cord. The at least one beat signal has a frequency within a range of more than 250 Hz to about 15,000 Hz.

Abstract: Apparatus, systems and methods are provided for prevention and/or remediation of cardiac arrhythmias, e.g. optimizing anti-tachycardia pacing (ATP) algorithms. More particularly, implantable devices are provided that measure and treat cardiac arrhythmias. By monitoring the ATP attempt from additional electrodes, far-field morphology analyzes, and/or measuring the return interval from a failed ATP attempt; the devices may estimate when entrainment has occurred, the amount of delay within the reentrant tachycardia, and/or tachycardia termination/acceleration. These variables and occurrences can be used to optimize the first and/or subsequent ATP attempts. Furthermore, other exemplary embodiments describe methods to integrate electrical restitution properties into the design of ATP pacing algorithms to facilitate tachycardia termination.

Abstract: An implantable medical device having a housing that encloses a pulse generator and a sensing module includes a housing-based cathode electrode electrically coupled to the pulse generator and to the sensing module. A sensing extension extending from the housing proximal end includes an anode electrode electrically coupled to the sensing module for sensing cardiac electrical signals. The sensing extension includes a flotation member that causes the sensing extension to extend away from the housing along a direction of flowing blood when the implantable medical device is deployed within a cardiovascular system of a patient.

Abstract: An implantable medical device system includes an extracardiac sensing device and an intracardiac pacemaker. The sensing device senses a P-wave attendant to an atrial depolarization of the heart via housing-based electrodes carried by the sensing device when the sensing device is implanted outside the cardiovascular system and sends a trigger signal to the intracardiac pacemaker in response to sensing the P-wave. The intracardiac pacemaker detects the trigger signal and schedules a ventricular pacing pulse in response to the detected trigger signal.

Abstract: Devices and methods for improving device therapy such as cardiac resynchronization therapy by determining a value for a device parameter are described. An ambulatory medical device (AMD) can include a sensor circuit to sense a physiological signal and generate two or more signal metrics, and detect an event of worsening cardiac condition using the two or more signal metrics. In response to the detection of worsening cardiac condition, the AMD can determine, for a stimulator, a value of at least one stimulation parameter based on temporal responses of two or more signal metrics. The temporal responses include near-term and long-term responses to the stimulation. The AMD can program the stimulator with the determined parameter value, and generate stimulation according to the determined parameter value to stimulate target tissue.

Abstract: A system includes a pulse generator including a can electrode and a lead couplable to the pulse generator, the lead including a distal coil electrode and a proximal coil electrode, wherein both of the coil electrodes are electrically uncoupled from the can electrode such that a unipolar sensing vector is provided between at least one of the coil electrodes and the can electrode.

Abstract: Improved external chargers for charging an implantable medical device, and particularly useful in charging a plurality of such devices, are disclosed. Each of the various embodiments include a plurality of field customization coils for customizing the magnetic charging field generated by the external charger such that the magnetic charging field is not radially symmetric. For example, one embodiment includes a primary coil with a plurality of field customization coils distributed radially with respect to the coil. The generated magnetic charging field can be rendered radially asymmetric by selectively activating or disabling the field customization coils in response to data quantifying the coupling between the various implants and the field customization coils in the charger.

Abstract: A feedthrough subassembly for an active implantable medical device includes a metallic ferrule having a conductive ferrule body, at least one surface disposed on a device side, and a ferrule opening passing through the at least one surface. An insulator body hermetically seals the ferrule opening of the conductive ferrule body by at least one of a first gold braze ceramic seal, a glass seal or a glass-ceramic seal. At least one hermetically sealed conductive pathway is disposed through the insulator body. At least one pocket formed in the at least one surface has a gold pocket pad disposed within. When the first gold braze ceramic seal is present, the first gold braze ceramic seal and the gold pocket pad are not physically touching one another.

Abstract: In some examples, a feedthrough assembly a ferrule including a base portion and at least one projection extending from the base portion; a capacitive filter positioned adjacent the base portion of the ferrule such that an outer wall of the capacitive filter faces an inner wall of the at least one projection of the ferrule; a conductive pin extending through an aperture in the ferrule and an aperture in the capacitive filter; and an electrically conductive material between the inner wall of the at least one projection of the ferrule and outer wall of the capacitive filter that electrically couples the ferrule and the capacitive filter to ground the capacitive filter, wherein the inner wall of the at least one projection of the ferrule and the outer wall of the capacitive filter are tapered.

Abstract: A device configured to deliver and deploy an implantable medical device (IMD) includes a handle assembly and a shaft extending distally therefrom. A device containment housing configured to accommodate the IMD is coupled to the distal region of the shaft. At least one of the shaft and device containment housing includes a compressible region that is configured to compress by an amount that is related to an applied force. The device may include a first position indicator and a second position indicator. An applied force causes the compressible region to compress by an amount that is related to the applied force, causing a change in distance between the first position indicator and the second position indicator and thus providing an indication of the applied force.

Abstract: The present invention concerns an optoelectronic stimulating device for use in a medical treatment involving delivering an electrical current to an electrically excitable tissue (Zbio) by means of two electrodes (3n, 3p) electrically coupled to said tissue, said optoelectronic stimulating device comprising: (a) a source (4) of electrical impulses, which is electrically connected to (b) a source of light emission (2), in optical communication with (c) a photovoltaic cell (1) electrically connected to two electrodes (3n, 3p) for establishing two electrical contacts with said tissue and thus forming an electrical stimulating circuit fed by the photovoltaic cell (1) which is energized by the radiation of the source of light emission (2).

Abstract: An extra-cardiovascular implantable cardioverter defibrillator (ICD) is configured to induce a tachyarrhythmia by charging a high voltage capacitor to a voltage amplitude and delivering a series of pulses to a patient's heart by discharging the capacitor via an extra-cardiovascular electrode vector. Delivering the series of pulses includes recharging the high-voltage capacitor during an inter-pulse interval between consecutive pulses of the series of pulses.

Abstract: An implantable medical device system includes a pacemaker and an implantable cardioverter defibrillator (ICD). The pacemaker is configured to confirm a hemodynamically unstable rhythm based on an activity metric determined from an activity sensor signal after detecting a ventricular tachyarrhythmia and withhold anti-tachycardia pacing (ATP) pulses in response to confirming the hemodynamically unstable rhythm. The pacemaker may deliver ATP when a hemodynamically unstable rhythm is not confirmed based on the activity metric. The ICD is configured to detect the ATP and withhold a shock therapy in response to detecting the ATP in some examples.

Abstract: An rTMS coil or set of coils are designed to affect multiple regions of the brain with synchronous magnetic field pulses. Multiple coils aligned over the targeted regions of interest, or a single coil that is stretched or enlarged in a shape that allows the magnetic field to affect the areas of interest are disclosed. Also disclosed is a method of optimizing repetitive transcranial magnetic stimulation (rTMS) treatments.

Abstract: Embodiments of the invention include methods of treating a patient with physiological responses arising from an injury or condition, such as post-operative pain, traumatic brain injury, and cognitive defects. These treatment methods can include the steps of generating a pulsed electromagnetic field from a pulsed electromagnetic field source which is configured to simultaneously increase the rate of ion-dependent signaling, such as CaM/NO/cGMP signaling and to minimize the rate of inhibition of such signaling by natural compounds and applying the pulsed electromagnetic field in proximity to a target region affected by the injury or condition for a first treatment interval followed by an inter-treatment period with no electromagnetic field between treatment intervals to reduce a physiological response to the injury or condition.

Abstract: A system and method of illuminating tissue, particularly within the cranial cavity, through the mouth or nose. The system includes a light source and a power source for powering the light source. Optics are included for directing light from the light source towards the cranial cavity when the apparatus is inserted into a cavity of the head. Light from the light source and output from the optic provides cellular interaction treatment toward a specified area of the head region. Providing illumination where there are already holes in the skull results in more efficient coupling of light to the cells.

Abstract: Methods, systems and devices are implemented in connection with light-responsive ion channel molecules. One such method is implemented using a light-activated ion channel molecule that responds to a light stimulus. The method includes engineering the light-activated ion channel molecule in a cell; and activating the ion channel molecule, in response to light stimulus that is provided to the ion channel molecule and that has properties that do not activate a ChR2 ion channel, to allow ions to pass through the light-activated ion channel molecule.

Abstract: Carriers for embodying radioactive seeds, as well as a device for loading and customizing brachytherapy carriers based on the principles of optimizing a more precise and predictable dosimetry, and adaptable to the geometric challenges of a tumor bed in a real-time setting. The present disclosure relates to a specialized loading device designed to enable a medical team to create a radionuclide carrier for each patient and tumor reliably, reproducibly and efficiently.

Abstract: A method for treating, preventing and/or reducing neurodegeneration in subjects with neurodegenerative disease, such as those neurodegenerative diseases that affect the eye, including glaucoma, using radiation, such as gamma radiation or X-ray radiation, either alone or together with a bone marrow transfer treatment. The method includes irradiating a targeted area of an animal, such as the eye region, with radiation, either alone or followed by injection with T-cell depleted bone marrow cells. Also a method for screening and/or selecting agents and/or treatment methods for inhibiting, treating and/or reducing neurodegeneration, particularly the neurodegeneration of the eye that occurs as a consequence of glaucoma.

Abstract: Disclosed is a layer structure for epidermal radionuclide therapy (brachytherapy) of a patient comprising, from a patient's view, a proximal adherent layer for applying the layer structure on the skin surface to be treated of a patient; a flexible, transparent carrier layer that from a patient's view is located in a distal direction on the adherent layer; and at least one radionuclide-containing emission layer located on the carrier layer, the adherent layer and the carrier layer with regard to their components and thickness being formed such that they are essentially transparent for ? and ? radiation. The layer structure is suited particularly for radiotherapeutic treatment of the basal-cell carcinoma (BCC) and the squamous cell carcinoma (SCC). With the aid of the layer structure, geometrically complex skin lesions caused by a tumor, as occurring e.g. on the outer edge of the auricle, may be treated easily.

Abstract: In order to provide radiation dose estimation during a treatment, one or more characteristics of the patient are used. A camera captures the patient so that the characteristics (e.g., organ position) may be derived. Radiation exposure and/or absorption are determined from the characteristics. A Monte Carlo, machine-learnt, or other model estimates the dosage for different locations in the patient. During the treatment, the dosage may be presented as a warning when exceeding a threshold or other visualization.